Status:
COMPLETED
Quantification of Diclofenac 2.32% (Voltaren) in Rinse Water After Different Application Methods
Lead Sponsor:
HALEON
Conditions:
Healthy Participants
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The purpose of this study is to quantify the amount of diclofenac in rinse water after application of the test product (Voltaren® Schmerzgel forte; 2.32 percent \[%\]) containing 2.32% Diclofenac-N-Et...
Detailed Description
This will be an exploratory, open label, crossover study. Participants with healthy skin on the elbows and hands will be enrolled. The amount of diclofenac in rinse water after application of the test...
Eligibility Criteria
Inclusion
- Written informed consent to participate in the study.
- Willingness to actively participate in the study and to come to the scheduled visits.
- Female and/or male.
- From 18 to 70 years of age.
Exclusion
- Female participants: Pregnancy or lactation.
- Drug addicts, alcoholics.
- Acquired immunodeficiency syndrome (AIDS), human immunodeficiency virus (HIV)-positive or infectious hepatitis.
- Conditions which exclude a participation or might influence the test reaction/evaluation.
- Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area.
- Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years.
- A previous allergic reaction, sensitivity or intolerance to diclofenac or any of the other ingredients in Voltaren® Schmerzgel forte.
- Participants in whom asthma, angioedema, urticaria or acute rhinitis are precipitated by acetyl salicylic acid or other non-steroidal anti-inflammatory drugs (example, ibuprofen, naproxen et cetera).
- Documented allergies to cosmetic products.
- Active skin disease at the test area.
- Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, et cetera, at the test area that could influence the investigation.
- Any topical medication at the test area within the last 3 days prior to the start of the study.
Key Trial Info
Start Date :
March 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2025
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06954181
Start Date
March 26 2025
End Date
April 11 2025
Last Update
May 1 2025
Active Locations (1)
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1
SGS proderm GmbH
Schenefeld, Germany, 22869